Septra and Pregnancy

In studies on Septra and pregnancy, the medication increased the risk of cleft palate when it was given to pregnant animals. The antibiotic may also increase the risk of jaundice in a newborn, especially if a pregnant woman takes it late in pregnancy. If you are using Septra and pregnancy occurs, be sure to let your healthcare provider know.

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Is Septra Safe During Pregnancy?

Septra® (sulfamethoxazole/trimethoprim) is a prescription antibiotic often used to treat urinary tract infections (UTIs), although it is approved for other uses as well. At this time, it is not clear if Septra is safe for use during pregnancy. The manufacturer states that pregnant women should not take Septra unless the potential benefits outweigh the risks to the fetus and that women should never take Septra near the end of pregnancy.

What Is Pregnancy Category D?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.

In animal studies, Septra increased the risk of cleft palate. Also, trimethoprim (one of the components of Septra) increased the risk of fetal death in rats.

In humans, studies suggest that Septra may increase the risk of certain birth defects (like neural tube defects, heart problems, urinary tract defects, cleft palate, and club foot). It is thought that Septra might contribute to birth defects by decreasing folic acid; if it is necessary for a pregnant woman to take this medication, a folic acid supplement at a higher-than-normal dose for a pregnant woman might be helpful.

Of possibly greater concern, Septra might increase the risk of jaundice and, theoretically, kernicterus (brain damage caused by severe jaundice) in the newborn, especially if a pregnant woman takes Septra late in pregnancy.

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